(RTTNews) - GE HealthCare Technologies Inc. (GEHC) Wednesday said that it has received FDA 510(k) clearance for its innovative SIGNA MAGNUS 3.0T high-performance, head-only magnetic resonance imaging ...
PK Study Successfully Demonstrates that Fingerprint Sweat Provides Reliable Sample for Drug DetectionFDA 510(k) Clearance ...
GE HealthCare on Wednesday said U.S. regulators had cleared its head-only magnetic resonance imaging scanner. The Chicago-based medical technology company said the MRI device, called Signa Magnus, had ...
NEW YORK, Nov. 13, 2024 /PRNewswire/ -- Fourth Frontier, a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the Frontier X Plus from the U.S. FDA. The ...
Philips announced that the FDA granted 510(k) clearance for its new detector-based spectral computed tomography (CT) ...
Among those that voted "no", there were three who stated that if the FDA applied adequate special controls ... ProSense® system is marketed and sold worldwide for the indications cleared and approved ...
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first ...
BOSTON, Nov. 6, 2024 /PRNewswire/ -- Zeta Surgical announced today that its Zeta Navigation System has received 510 (k) ...